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Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma


Phase 2
18 Years
75 Years
Not Enrolling
Both
Kidney Cancer

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Trial Information

Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma


OBJECTIVES:

- Determine the efficacy of nonmyeloablative conditioning comprising fludarabine and
total-body irradiation followed by allogeneic hematopoietic stem cell transplantation,
in terms of 6-month and 12-month response rate, in patients with unresectable
metastatic renal cell carcinoma.

OUTLINE:

- Nonmyeloablative conditioning regimen: Patients receive fludarabine IV on days -4 to -2
and total-body irradiation (TBI) on day 0.

- Allogeneic hematopoietic stem cell transplantation (AHSCT): After TBI, patients undergo
AHSCT on day 0.

- Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56
followed by a taper until day 81. Patients also receive oral mycophenolate mofetil
twice daily on days 0-27 (if patient has a related donor) OR three times daily on days
0-29 and then twice daily on days 30-149 followed by additional tapering until day 180
(if patient has an unrelated donor).

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:

- Clear cell

- Papillary

- Medullary

- Metastatic disease

- Not amenable to curative surgery

- No CNS metastases

PATIENT CHARACTERISTICS:

Performance status

- Karnofsky 70-100%

Life expectancy

- More than 6 months

Hematopoietic

- Not specified

Hepatic

- Bilirubin < 2 times upper limit of normal (ULN)

- AST or ALT < 4 times ULN

Renal

- Creatinine clearance > 50 mL/min

Cardiovascular

- LVEF > 35%

- No symptomatic congestive heart failure

Pulmonary

- DLCO > 40% of predicted OR

- Total lung capacity or FEV_1 > 30% of predicted

PRIOR CONCURRENT THERAPY:

Biologic therapy

- More than 30 days since prior biologic therapy

Chemotherapy

- More than 30 days since prior chemotherapy

Radiotherapy

- More than 30 days since prior radiotherapy

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete and partial response) at 6 and 12 months after transplantation

Safety Issue:

No

Principal Investigator

Brandon M. Hayes-Lattin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000447207

NCT ID:

NCT00243009

Start Date:

June 2005

Completion Date:

April 2006

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • clear cell renal cell carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239